AutoContour Model RADAC V3
FDA 510(k) K230685 · Radformation, Inc.
510(k) numberK230685
Submission
- Device name
- AutoContour Model RADAC V3
- Applicant
- Radformation, Inc.
New York, NY, US - Received
- March 13, 2023
- Decision date
- April 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QKB – Radiological Image Processing Software For Radiation Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image…
Other 510(k)s with product code QKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262452 | AutoContour (RADAC V6)QKB · Special | Radformation, Inc. | 08/14/2026SE |
| K261306 | AI Contouring (VA10A)QKB · Traditional | Varian Medical Systems | 07/10/2026SE |
| K260528 | OncoStudioQKB · Traditional | Oncosoft. Inc., | 07/02/2026SE |
| K252548 | AI-Rad Companion Organs RTQKB · Traditional | Siemens Healthcare GmbH | 04/10/2026SE |
| K252190 | DeepBT Detector-PlusQKB · Traditional | Aitewan Biomedical Technology, Inc. | 04/10/2026SE |
| K253270 | Contour ProtégéAI+QKB · Traditional | Mim Software, Inc. | 03/27/2026SE |
| K260509 | AutoContour (RADAC V5)QKB · Special | Radformation, Inc. | 03/19/2026SE |
| K251306 | Seg Pro V3 (RT-300)QKB · Traditional | Ever Fortune.Ai, Co., Ltd. | 01/28/2026SE |
| K251351 | AccuContour 4.0QKB · Traditional | Manteia Technologies Co., Ltd. | 01/23/2026SE |
| K250780 | ARTAssistantQKB · Traditional | Manteia Technologies Co., Ltd. | 12/05/2025SE |
More from Manteia Technologies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261718 | EZFluence (RADEZ V2)IYE · Traditional | 08/31/2026SE |
| K262452 | AutoContour (RADAC V6)QKB · Special | 08/14/2026SE |
| K253962 | ClearCheck (RADCC V2.7)IYE · Traditional | 04/03/2026SE |
| K260509 | AutoContour (RADAC V5)QKB · Special | 03/19/2026SE |
| K252988 | ChartCheck (RADCH V1.6)IYE · Traditional | 01/05/2026SE |
| K252863 | ClearCalc Model RADCA V2.6MUJ · Traditional | 12/19/2025SE |
| K242729 | AutoContour (Model RADAC V4)QKB · Traditional | 12/09/2024SE |
| K220598 | AutoContour Model RADAC V2QKB · Traditional | 08/24/2022SE |
| K220583 | ClearCheck Model RADCC V2IYE · Traditional | 08/23/2022SE |
| K220582 | ClearCalc Model RADCA V2MUJ · Traditional | 08/22/2022SE |
Questions and answers
When was AutoContour Model RADAC V3 cleared by the FDA?
AutoContour Model RADAC V3 (K230685) received a 510(k) decision of Substantially Equivalent on April 14, 2023, 32 days after the submission was received.
What is the product code of K230685?
The FDA product code is QKB – Radiological Image Processing Software For Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.2050.